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Randomized-controlled Trial of Aftercare-Coordination by Phone for Depression and Anxiety

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Phone-based Aftercare-Coordination
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Depressive disorder (F32.x; F33.x; F34.1) and/or Anxiety disorder (F40.0; F40.1, F41.0; F41.1) according to ICD-10

Exclusion Criteria:

  • Concurrent outpatient psychotherapeutic treatment which will be continued after the inpatient rehabilitation treatment.
  • No knowledge of the German language
  • Risk of suicide
  • Acute psychosis or psychotic symptoms

Sites / Locations

  • University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Phone-based Aftercare-Coordination

Treatment as usual

Arm Description

After inpatient treatment patients receive six phone contacts of aftercare-coordination at intervals of two weeks carried out by therapists for 12 weeks. The intervention aims at supporting the patients in coordinating their aftercare treatment which can help to maintain or even improve longterm treatment outcome.

After inpatient treatment patients receive treatment as usual within routine care.

Outcomes

Primary Outcome Measures

Measure of the symptom severity - Beck Depression Inventory (BDI)

Secondary Outcome Measures

Measure of health related quality of life - Short Form 8 Health Survey (SF-8), Measure of health related quality of life (EQ-5D)
Proportion of patients who get routine outpatient aftercare treatment at follow up (6 months after the intervention)
Patient-rated acceptance and satisfaction with the intervention
Patients rate their acceptance of the intervention and their satisfaction using non-standardized items.

Full Information

First Posted
January 22, 2014
Last Updated
July 14, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT02044913
Brief Title
Randomized-controlled Trial of Aftercare-Coordination by Phone for Depression and Anxiety
Official Title
Randomized-controlled Trial of Aftercare-Coordination by Phone for Patients With Depression and Anxiety Subsequent to an Inpatient Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to test in a randomized controlled trial if aftercare-coordination by phone subsequent to inpatient treatment is an effective aftercare approach in the treatment of depression and anxiety.
Detailed Description
Depression and anxiety are among the most prevalent mental health problems and are associated with a high risk of chronification. Despite the large capacities in the German health care system only a small percentage of these patients receive treatment. Relevant barriers on the pathways of patients are communication und coordination difficulties between different services and providers.The aftercare subsequent to an inpatient treatment represents one of these interfaces. Here the aim is to consolidate the treatment outcomes and to minimize the so called rebound-effect, the reduction of the positive treatment effects after the inpatient treatment. Although evidence-based treatments for depression and anxiety disorders exist, treatment effects often decrease after treatment due to the lack of an integration of different steps in care. The method of a case management-based aftercare coordination by phone could be a promising approach to overcome the interface between inpatient treatment and aftercare: case management is a patient-centered and situation-based approach which comprises systematic tracking and support of patients by a case-manager. Primary goal is to coordinate and integrate services across treatment settings. This approach can help to maintain and even improve longterm treatment outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phone-based Aftercare-Coordination
Arm Type
Experimental
Arm Description
After inpatient treatment patients receive six phone contacts of aftercare-coordination at intervals of two weeks carried out by therapists for 12 weeks. The intervention aims at supporting the patients in coordinating their aftercare treatment which can help to maintain or even improve longterm treatment outcome.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
After inpatient treatment patients receive treatment as usual within routine care.
Intervention Type
Behavioral
Intervention Name(s)
Phone-based Aftercare-Coordination
Intervention Description
After inpatient treatment patients receive six phone contacts of aftercare-coordination at intervals of two weeks carried out by therapists for 12 weeks. The intervention is case-management orientated and aims at supporting the patients in finding and organising an adequate aftercare treatment.
Primary Outcome Measure Information:
Title
Measure of the symptom severity - Beck Depression Inventory (BDI)
Time Frame
Change in the BDI from the beginning of the intervention to follow up (6 months after termination of the intervention)
Secondary Outcome Measure Information:
Title
Measure of health related quality of life - Short Form 8 Health Survey (SF-8), Measure of health related quality of life (EQ-5D)
Time Frame
Change in the SF-8 and EQ-5D from the beginning of the intervention to follow up (6 months after termination of the intervention)
Title
Proportion of patients who get routine outpatient aftercare treatment at follow up (6 months after the intervention)
Time Frame
6 months after termination of the intervention
Title
Patient-rated acceptance and satisfaction with the intervention
Description
Patients rate their acceptance of the intervention and their satisfaction using non-standardized items.
Time Frame
Approximately 3 months (end of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Depressive disorder (F32.x; F33.x; F34.1) and/or Anxiety disorder (F40.0; F40.1, F41.0; F41.1) according to ICD-10 Exclusion Criteria: Concurrent outpatient psychotherapeutic treatment which will be continued after the inpatient rehabilitation treatment. No knowledge of the German language Risk of suicide Acute psychosis or psychotic symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. phil. Hanne Melchior
Organizational Affiliation
University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf, Centre of Psychosocial Medicine, Department of Medical Psychology
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25897757
Citation
Kivelitz L, Schulz H, Melchior H, Watzke B. Effectiveness of case management-based aftercare coordination by phone for patients with depressive and anxiety disorders: study protocol for a randomized controlled trial. BMC Psychiatry. 2015 Apr 22;15:90. doi: 10.1186/s12888-015-0469-y.
Results Reference
derived

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Randomized-controlled Trial of Aftercare-Coordination by Phone for Depression and Anxiety

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